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YY/T 0799-2010

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YY/T 0799-2010 英文版 1460 购买 现货,9秒内自动发货PDF,有增值税发票。 医用气体低压软管组件 有效

   
标准详细信息 YY/T 0799-2010; YY/T0799-2010; YYT 0799-2010; YYT0799-2010
中文名称: 医用气体低压软管组件
英文名称: Low-pressure hose assemblies for use with medical gases
行业: 医药行业标准 (推荐)
中标分类: C46
国际标准分类: 11.040.10
字数估计: 28,000
发布日期: 2010-12-27
实施日期: 2012-06-01
引用标准: GB/T 7144-1999; GB/T 9575-2003; GB/T 5563-2006; GB/T 14905-1994; YY 0801.1-2010; YY/T 0316-2008; ISO 15001; EN 1089-3-2004; AS 2896-1998
采用标准: ISO 5359-2008, MOD
起草单位: 上海市医疗器械检测所、上海医疗器械股份有限公司
归口单位: 全国麻醉和呼吸设备标准化技术委员会(SAC/TC 116)
标准依据: 国家食品药品监督管理局公告2010年第97号
发布机构: 国家食品药品监督管理局
范围: 本标准规定了用于下列医用气体的低压软管组件的要求:氧气;氧化亚氮(笑气);医用空气;氦气;二氧化碳;氙气;上述气体的专用混合气;富氧空气;驱动手术器械用空气;驱动手术器械用氮气;真空。本标准规定了对于医用气体的不可互换的螺纹(NIST)接头、直径限位的安全系统(DISS)接头和管接头限位系统(SIS)接头的配置, 并规定了不可互换的螺纹(NIST)接头的尺寸。本标准未规定:用于驱动手术器械用空气的供应和排放的同轴软管的要求;电导率的要求。本标准未规定软管组件的预期用途。

YY/T 0799-2010
Low-pressure hose assemblies for use with medical gases
ICS 11.040.10
C46
中华人民共和国医药行业标准
医用气体低压软管组件
(ISO 5359:2008,MOD)
2010-12-27发布
2012-06-01实施
国家食品药品监督管理局 发 布
目次
前言 Ⅰ
引言 Ⅱ
0.1 概述 Ⅱ
0.2 用于软管组件的螺纹接头的标准化 Ⅱ
1 范围 1
2 规范性引用文件 1
3 术语和定义 2
4 通用要求 4
5 测试方法 14
6 标志、颜色标识和包装 16
7 制造商提供的信息 18
附录A(资料性附录) 基本原理 19
附录B(资料性附录) 环境方面 20
附录C(资料性附录) 据报告的颜色标识和医用气体术语在各地区和国家间的差异 21
参考文献 23
前言
本标准按照GB/T 1.1-2009给出的规则起草。
本标准修改采用国际标准ISO 5359:2008《医用气体低压软管组件》(英文版)。
本标准与ISO 5359:2008相比较,主要差异包括:
---ISO 5359:2008的引言转化为本标准的引言,删除了ISO 5359:2008的前言。
---ISO 5359:2008中引用的ISO 国际标准,有对应被采用为国家标准和行业标准的,本部分以引
用这些国家标准和行业标准作为规范使用;现无对应被采用为国家标准和行业标准,则以所引
用的ISO 国际标准作为规范使用。
---将ISO 5359:2008标准中表6颜色标识由根据EN1089-3:2004改为根据GB 7144-1999。
本标准由全国麻醉和呼吸设备标准化技术委员会(SAC/TC116)归口。
本标准起草单位:上海市医疗器械检测所、上海医疗器械股份有限公司。
本标准主要起草人:王伟、傅国庆。
引 言
0.1 概述
本标准的制订,是因为需要一个安全的方法来将医疗设备连接至一个固定的医用气体管路系统或
其他医用气体供应系统,使其满足输送不同气体、或不同压力下同种气体的软管组件不得互换的要求。
固定的医用气体管道一旦安装完毕,就不能被随意移动,并遵循规定程序使用,以防止医用气体的交叉
混用或污染的可能性。然而,在相对较短的使用周期内,软管组件频繁地与医疗设备和固定的气体管道
连接、断开会出现自然磨损、撕裂、误用和滥用等问题。
虽然意识到没有一个系统是绝对安全的,本标准还是包含了防止因使用软管组件而带来的可预见
危害的必要规定。操作者宜时时警惕因外部因素造成损害的可能性,因此,宜进行定期检查和维修,以
确保软管组件持续满足本标准的要求。
本标准特别注意以下问题:
---材料的适用性;
---气体专用性;
---清洁度;
---测试;
---鉴别;
---信息提供。
本标准中某些要求的基本原理在附录A中给出。这些条款在正文中用“*”表示。
0.2 用于软管组件的螺纹接头的标准化
虽然期望有一个螺纹接头的统一国际标准,但从目前的情况来看制定统一的标准还不成熟。然而,
随着国家标准数量的迅速增加,最终将有可能导致用于不同气体的元器件之间的交叉混用危险,因此,
本标准选择了三种螺纹接头系统。
三种不可互换的接头系统分别是:DISS(直径限位的安全系统)、NIST(不可互换的螺纹)和SIS
(管接头限位的系统)。表1和表5详细说明了DISS、NIST和SIS接头可用的气体和混合气体。NIST
接头的尺寸在表2、表3和表4以及图2、图3、图4和图5中给出。
作为螺纹接头的替代品,气体专用“快速接头”可用于软管组件的进气口(真空时为出气口),也就是
用于连接软管组件到固定管道。在任何一个卫生保健机构中,不同设计的快速接头系统间不能互换。
医用气体低压软管组件
1 范围
1.1* 本标准规定了用于下列医用气体的低压软管组件的要求:
---氧气;
---氧化亚氮(笑气);
---医用空气;
---氦气;
---二氧化碳;
---氙气;
---上述气体的专用混合气;
---富氧空气;
---驱动手术器械用空气;
---驱动手术器械用氮气;
---真空。
其目的主要是确保气体专用性,防止不同气体传输系统间的交叉连接。这些软管组件预期用于最
1.2 本标准规定了对于医用气体的不可互换的螺纹(NIST)接头、直径限位的安全系统(DISS)接头和
管接头限位系统(SIS)接头的配置,并规定了不可互换的螺纹(NIST)接头的尺寸。
1.3 本标准未规定:
---用于驱动手术器械用空气的供应和排放的同轴软管的要求;
---电导率的要求。
1.4 本标准未规定软管组件的预期用途。
注:在下列标准中规定了一些预期用途的例子:
a) 终端设备和医疗设备之间(ISO 9170-1,GB 9706.28[7],GB 9706.29[8]);
b) 固定管路系统和该系统的终端设备之间(ISO 7396-1[10],YY0733[13]);
d) 应急供应系统和管道系统的应急和维护输入口之间(ISO 10524-1[12],ISO 7396-1);
e) 应急供应系统和医疗设备之间(ISO 10524-1,ISO 10524-3[16],GB 9706.28,GB 9706.29)。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文
件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
GB 7144-1999 气瓶颜色标志
GB/T 9575-2003 工业通用橡胶和塑料软管 内径尺寸及公差和长度公差(ISO 1307:1992)
GB/T 5563-2006 橡胶和塑料软管及软管组合件 静液压试验方法(ISO 1402:1994,IDT)
GB/T 14905-1994 橡胶和塑料软管各层间粘合强度测定(ISO 8033:1991)
(ISO 9170-1:2008,MOD)
YY/T 0316-2008 医疗器械 风险管理对医疗器械的应用(ISO 14971:2007)

YY/T 0799-2010
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 46
Low-pressure hose assemblies for use with
medical gases
医用气体低压软管组件
(ISO 5359.2008, MOD)
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 1, 2012
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3 
Introduction ... 4 
0.1 General ... 4 
0.2 Standardization of screw-threaded connectors for use in hose assemblies ... 4 
1  Scope ... 6 
2  Normative references ... 7 
3  Terms and definitions ... 8 
4  General requirements ... 11 
5  Test methods ... 24 
6  Marking, color coding and packaging ... 27 
7 Information to be supplied by the manufacturer ... 29 
Annex A ... 30 
Annex B ... 31 
Annex C ... 32 
Bibliography ... 34 
Foreword
This Standard is drafted according to the provisions given in GB/T 1.1-2009.
This Standard modifies and adopts international standard ISO 5359.2008 “Low-pressure
Hose Assemblies for Use with Medical Gases” (English version).
Compared with ISO 5359.2008, main differences of this Standard include.
— Convert the introduction of ISO 5359.2008 into introduction of this Standard; delete
the foreword of ISO 5359.2008.
— For ISO international standards that are cited in ISO 5359.2008, if there are
corresponding national standards or industrial standards, then this Standard cites
such national standards or industrial standards as the reference norms; if there is no
existing corresponding national standard or industrial standard, the such cited ISO
international standards are cited as the reference norms.
— Change the color mark in table 6 of ISO 5359.2008 from .according to EN
1089-3.2004” to “according to GB 7144-1999”.
This Standard shall be under the jurisdiction of National Technical Committee of
Anesthesia and Respiratory Equipment Standardization (SAC/TC 116).
Drafting organizations of this Standard. Shanghai Testing & Inspection Institute for
Medical Devices, and Shanghai Medical Instruments Co., Ltd.
Main drafters of this Standard. Wang Wei, and Fu Guoqing.
Introduction
0.1 General
This Standard has been prepared in response to the need for a safe method of connecting
medical equipment to a fixed medical gas pipeline system or other medical gas supply
system such that hose assemblies carrying different gases, or the same gas at different
pressures, cannot be interchanged. Fixed medical gas pipelines, once installed, are rarely
disturbed and are subjected to commissioning procedures to avoid the possibility of
cross-connections or contamination of the medical gas conveyed. However, hose
assemblies are subjected to physical wear and tear, misuse and abuse throughout their
relatively short service life and are frequently connected to, and disconnected from, the
medical equipment and the fixed pipeline.
While recognizing that no system is absolutely safe, this Standard includes those
requirements considered necessary to prevent foreseeable hazards arising from the use
of hose assemblies. Operators should be continually alert to the possibility of damage
being caused by external factors, and therefore regular inspection and repair should be
undertaken to ensure that hose assemblies continue to meet the requirements of this
Standard.
This Standard pays particular attention to.
— suitability of materials;
— gas-specificity;
— cleanliness;
— testing;
— information supplied.
Rationales for some of the requirements of this Standard are given in Annex A. Such
requirements are indicated by the asterisk (*) after the clause number in the main text.
0.2 Standardization of screw-threaded connectors for use in hose assemblies
Whilst the desirability of achieving agreement on a single International Standard for
screw-threaded connectors has never been in doubt, the present pattern of usage has
made such agreement impossible. Nevertheless, fears that proliferation of national
standards or practices will eventually result in potentially dangerous cross-connection
between components for different gases have led to the choice of three screw-threaded
The three systems of connectors, which are non-interchangeable, are diameter-index
safety system (DISS), non-interchangeable screw-threaded (NIST) and sleeve indexed
system (SIS). Tables 1 and 5 detail those gases and gas mixtures for which DISS, NIST
and SIS connectors have been allocated. Dimensions of NIST connectors are given in
Tables 2, 3 and 4 and Figures 2, 3, 4 and 5.
As an alternative to the screw-threaded connector, a "quick connector" which is
gas-specific can be used at the inlet (outlet for vacuum) of the hose assembly, i.e. to
connect the hose assembly to the fixed pipeline. Quick-connector systems of differing
design should be non-interchangeable with each other in any one healthcare facility.
medical gases
1 Scope
1.1* This Standard specifies requirements for low-pressure hose assemblies intended for
use with the following medical gases.
— oxygen;
— nitrous oxide;
— medical air;
— helium;
— carbon dioxide;
— specified mixtures of the gases listed above;
— oxygen-enriched air;
— air for driving surgical tools;
— nitrogen for driving surgical tools;
— vacuum.
It is intended in particular to ensure gas-specificity and to prevent cross-connection
between systems conveying different gases. These hose assemblies are intended for use
at maximum operating pressures of less than 1400 kPa.
1.2 This Standard specifies the allocation of (NIST), (DISS), (SIS) connectors to medical
connectors.
1.3 This Standard does not specify.
— requirements for coaxial hoses used for the supply and disposal of air for driving
surgical tools;
— requirements for electrical conductivity.
1.4 This Standard does not specify the intended uses of hose assemblies.
NOTE. Some examples of intended use are specified in following standards.
a) between a terminal unit and medical equipment (ISO 9170-1, GB 9706.28 [7], GB
9706.29 [8]);
0733[13]);
c) between a terminal unit and a second terminal unit (ISO 7396-1);
d) BETWEEN an emergency supply AND an emergency and maintenance inlet point of a
pipeline system (ISO 10524-1[12], ISO 7396-1);
e) between an emergency supply and medical equipment (ISO 10524-1, ISO 10524-3[16],
GB 9706.28, GB 9706.29).
2 Normative references
The articles contained in the following documents have become part od this document
when they are quoted herein. For the dated documents so quoted, all the modifications
document.
GB 7144-1999 Colored cylinder mark for gases
GB/T 9575-2003 Colored cylinder mark for gases (ISO 1307.1992)
GB/T 5563-2006 Rubber and plastics hoses and hose assemblies – Hydrostatic
testing (idt ISO 1307.1992)
GB/T 14905-1994 Rubber and plastics hose — Determination of adhesion between
components (ISO 8033.1991)
YY 0801.1-2010 Terminal units for medical gas pipeline systems — Part 1.Terminal
units for use with compressed medical gases and vacuum (ISO 9170-1.2008, MOD)
devices (ISO 14971.2007)
ISO 15001 Anesthetic and respiratory equipment — Compatibility with oxygen
EN 1089-3.2004 Transportable gas cylinders — Gas cylinder identification (excluding
LPG) — Part 3. Color coding
AS 2896-1998 Medical gas systems — Installations and testing of non-flammable
medical gas pipeline systems
condition in which a single means for protection against a safety hazard in equipment is
defective or a single external abnormal condition is present
3.16
sleeve-index system connector
any of a range of male and female components intended to maintain gas-specificity by the
allocation of a set of different diameters to the mating connectors for each particular gas
3.17
socket
female part of a terminal unit which is either integral or attached to the base block by a
gas-specific interface and which contains the gas-specific connection point
3.18
terminal unit
makes connections and disconnections
4 General requirements
4.1 Safety
Hose assemblies shall, when transported, st...
   
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